Please find the session links next to their corresponding agenda item.


Overview of FDA and Regulatory Processes
Steven S. Tjoe, Senior Associate, Goodwin Procter LLP

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Please find the session links next to their corresponding agenda item.

Wednesday, March 16

11:00 AM 

FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI

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11:05 AM– 12:20 PM 

Introduction to FDA Review and Approval of Biological Products
Catherine M. Cook, Principal for Regulatory Policy, Greenleaf Health, Inc.

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12:20 – 12:30 PM 


12:30 – 1:45 PM 

Regulation of Biological/Product Development
Christopher M. Mikson, Partner, DLA Piper LLP

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1:45 – 1:55 PM


1:55 – 3:10 PM

Human Cellular and Tissue Based Products (HCT/P), Cell Therapy and Gene Therapy
Gail Javitt, Partner, Hyman, Phelps & McNamara, PC

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3:10 – 3:20 PM


3:20 – 4:35 PM

Biological Product Approval, Vaccines, Emergency Use Authorization
Christina M. Markus, Partner, King & Spalding LLP
Eva Temkin, Partner, King & Spalding LLP

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